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Trial registered on ANZCTR


Registration number
ACTRN12617001495314p
Ethics application status
Not yet submitted
Date submitted
10/09/2017
Date registered
23/10/2017
Date last updated
23/10/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating an online intervention for General Practitioners (GPs) to use delayed prescribing for acute respiratory infections in general practice
Scientific title
Evaluating an online intervention for General Practitioners to use delayed prescribing for acute respiratory infections in general practice
Secondary ID [1] 292844 0
Nil known
Universal Trial Number (UTN)
Not applicable
Trial acronym
The GP4DP Trial
Linked study record
Not applicable

Health condition
Health condition(s) or problem(s) studied:
Respiratory Tract Infections 304944 0
Condition category
Condition code
Infection 304270 304270 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: The GP4DP Trial
Purpose: The online intervention aims to facilitate delayed prescribing so if doctors and patients decide antibiotics are necessary, delayed prescribing is the first option and that it is carried out appropriately. Delayed prescribing, also called 'wait-and-see' prescribing, is when a General Practitioner (GP) makes an antibiotic prescription available during the consultation but asks the patient to delay its use to see if symptoms will resolve first.
Procedures: GPs will be given access to the online intervention
Materials: The intervention is an online space where GPs can access information on how to do delayed prescribing (short video), evidence of success and resources to give to the patient to take home. Resources will include an information sheet for patients to take home explaining what infection they have, how long it usually lasts, how they can manage their symptoms and what to look for if it worsens.
Who provides the intervention: The intervention is online.
When and how much: After recruitment, GPs will be given access to the website. It can be accessed at any time including the consultation. No face-to-face training will be provided. It is intended the website can be used on an ongoing basis, however, the duration of the intervention for this study will be 3 months during the study. The researchers will also be examining the GPs prescribing during the same three months the year before.
Tailoring: The intervention is not planned to be tailored in anyway, although the participants may contact and ask the research team questions about delayed prescribing.
Fidelity: The online intervention will be piloted and feedback will used for amendments before trial.
Intervention code [1] 299090 0
Behaviour
Comparator / control treatment
‘Usual care’. GPs at the control practices will not receive access to the online intervention until completion of trial when it will be offered gratis.
Control group
Active

Outcomes
Primary outcome [1] 303330 0
Rate of antibiotic dispensing of the target antibiotics for each GP (number of consultations for which one of the target antibiotics was dispensed per year).
Target antibiotics are those routinely used for ARIs (amoxicillin, roxithromycin, amoxy-clav, cefaclor, and cephalexin).
Antibiotic dispensing data for the target antibiotics will be collected from the Pharmaceutical Benefits Scheme, by prescriber number. Medicare Benefits Scheme -recorded consultations will be collected by provider number.
Timepoint [1] 303330 0
Baseline: the same three months of the trial the previous year (June, July and Aug 2017) and, the three months during the trial (June, July and Aug 2018)
Secondary outcome [1] 338659 0
There is no secondary outcome
Timepoint [1] 338659 0
There is not secondary outcome timepoint.

Eligibility
Key inclusion criteria
General practitioners in Australia; practising GPs
Minimum age
25 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Is not practicing as a GP currently;
Has participated in a research study aimed at reducing antibiotic prescribing in the last 2 years.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Practice will be randomised using a block-permuted design. The randomisation sequence will be produced by the trial statistician who will have no role in recruiting practices or consenting GPs. She will also provide allocation concealment by keeping the randomisation lists secure and only randomising practices when completed consent forms are received. The researchers responsible for recruitment will contact the statistician to randomise a practice.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be produced using the computer generated random numbers by the trial statistician.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Power calculation:
From the Cochrane review of ‘Delayed antibiotics for respiratory infections’ the reduction in antibiotics used by patients was a 61% absolute decrease (Delayed prescribing resulted in 32% of patients using antibiotics compared to 93% of patients in the immediate prescription group). As the 10 studies in the review were more complex than this one we propose a reduction in absolute prescribing by 20%. For the primary outcome measure of antibiotic dispensing, power calculations suggest a required sample size of 10 practices (5 intervention, 5 control, a total of about 50 GPs, assuming an average of 5 consenting GPs per practice). With 80% power, a significance level of 5% and an intra-class correlation coefficient for the effect of clustering of 0.05, we will require 10 practices (or about 50 GPs) to detect a relative reduction in the rate of prescribing.
Statistical analysis:
The analysis will use Poisson regression with the mean rate of dispensing over 3 months, for each GP as the outcome, adjusted for previous prescribing rate (12 months prior to randomised action and 3 months during the trial). Using multi-level model that accounts for nesting of monthly rates within GP, and GPs within practices. We will also collect the total number of MBS-recorded consultations for each GP for the same periods so that adjustment can be made based on the number of billed consultations for each GP. All practices will be included in the analysis, on the intent-to-treat basis, even if GPs did not use the intervention or discontinued use during the 3 months period.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 297477 0
University
Name [1] 297477 0
University of the Sunshine Coast
Address [1] 297477 0
Faculty of Science, Health, Education and Engineering
University of the Sunshine Coast
90 Sippy Downs Dr
Sippy Downs
QLD 4556
Country [1] 297477 0
Australia
Funding source category [2] 297479 0
University
Name [2] 297479 0
Bond University
Address [2] 297479 0
Faculty of Health Science and Medicine
Bond University
University Drive
Robina, QLD 4229
Country [2] 297479 0
Australia
Primary sponsor type
University
Name
University of the Sunshine Coast
Address
Faculty of Science, Health, Education and Engineering
University of the Sunshine Coast
90 Sippy Downs Dr
Sippy Downs
QLD 4556
Country
Australia
Secondary sponsor category [1] 296473 0
University
Name [1] 296473 0
Bond University
Address [1] 296473 0
Faculty of Health Science and Medicine
Bond University
University Drive
Robina, QLD 4229
Country [1] 296473 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 298579 0
Human Research Ethics Committee of the University of the Sunshine Coast
Ethics committee address [1] 298579 0
Research Ethics
Block B
University of the Sunshine Coast
90 Sippy Downs Dr
Sippy Downs
QLD 4556
Ethics committee country [1] 298579 0
Australia
Date submitted for ethics approval [1] 298579 0
31/10/2017
Approval date [1] 298579 0
Ethics approval number [1] 298579 0

Summary
Brief summary
Antibiotics treat infections by killing bacteria. Antibiotic resistance occurs when an antibiotic has lost its ability to kill the bacteria; the bacteria has become resistant to the antibiotic and continues to multiply. One of the main reasons antibiotics lose their effectiveness is we take antibiotics when we don’t need them. Most antibiotics are prescribed for respiratory tract infections, in the community, that often get better without the need for medical intervention. There are many strategies to help doctors and patients to reduce antibiotic use in the community. One of these strategies is called ‘delayed prescribing’. Delayed prescribing, also called ‘wait-and-see prescribing’, is the process whereby a general practitioner (GP) makes available an antibiotic prescription during the consultation, but asks the patient to delay its use to see if symptoms will resolve first. This has been used in other countries very successfully but has never been trialed in Australia. The GP4DP trial wants to test if delayed prescribing can help reduce antibiotic use in community for people who present to their GP with respiratory tract infections. This trial will ask GPs not to prescribe antibiotics unnecessarily and if they do think it might be necessary, to ask the patient to wait and see if the illness will get better on its own before taking the antibiotic. Other studies have shown that most people do wait before taking the antibiotics, complications are extremely rare and the amount of people who present to the Emergency Department does not increase.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2040 2040 0 0
Attachments [2] 2041 2041 0 0

Contacts
Principal investigator
Name 77542 0
Ms Lucy Sargent
Address 77542 0
Faculty of Science, Health, Education and Engineering
University of the Sunshine Coast
90 Sippy Downs Dr
Sippy Downs
QLD 4556
Country 77542 0
Australia
Phone 77542 0
+61 400 447335 (m)
Fax 77542 0
Email 77542 0
lsargent@usc.edu.au
Contact person for public queries
Name 77543 0
Ms Lucy Sargent
Address 77543 0
Faculty of Science, Health, Education and Engineering
University of the Sunshine Coast
90 Sippy Downs Dr
Sippy Downs
QLD 4556
Country 77543 0
Australia
Phone 77543 0
+61 7 5430 2823
Fax 77543 0
Email 77543 0
lsargent@usc.edu.au
Contact person for scientific queries
Name 77544 0
Ms Lucy Sargent
Address 77544 0
Faculty of Science, Health, Education and Engineering
University of the Sunshine Coast
90 Sippy Downs Dr
Sippy Downs
QLD 4556
Country 77544 0
Australia
Phone 77544 0
+61 400 447335
Fax 77544 0
Email 77544 0
lsargent@usc.edu.au

No data has been provided for results reporting
Summary results
Not applicable